Scientist 3 - Drug Product Microbiologist - FSP

Found in: beBee S US - 3 weeks ago

Northeast, United States Parexel Full time

We are looking to fill a microbiologist position working as a full-time employee of Parexel FSP on long-term assignment onsite at one of our clients in Rahway, NJ.

Qualifications

Bachelor’s degree required; concentration in a scientific or applied discipline strongly preferredA minimum of 1-2 years of experience in pharmaceutical microbiology related position required (occasional overtime)

Required Skills and Experience

Solid microbiology foundation with experience in performing product testingProven technical writing skills (SOPs, protocols)

Desired Skills and Experience

Experience in the pharmaceutical/biotechnology industries preferredExperience with environmental monitoring and water testing preferred

Responsibilities

MICROBIOLOGICAL PRODUCT ANALYSIS

Analyze samples and compile meaningful dataPerform Investigations and prepare/respond to CAPAReview, revise Test Procedures/Standard Operating ProceduresAd Hoc workRotational on-call assignments

MICROBIOLOGICAL ACTIVITIES Include (but not limited to):

Receive, verify & Log in samplesReturn templates and shipping paperwork when and where appropriateCompile and trend dataPrepare and ship materials offsite for ID/testing (when applicable)Environmental monitoringStock culture management and quality control of sameBiological indicator managementBioburden testingWater samplingMicrobiological media management and quality control of sameSterilization activitiesResearch experiments as deemed appropriate by client managementMethod Validation/QualificationOther microbiological activitiesRotational on-call assignments for responding to alarms

CALIBRATIONS:

Execute “Before-Use” calibrations prior to performing testingReview calibration data within the ELNPrepare and submit equipment for calibrations (offsite or onsite)Complete calibration/PM paperworkPROCAL Entries

GMP ACTIVITIES:

Prepare GMP documentation as requested by managementPerform laboratory sanitizations and ensure cleanliness of laboratory workspacePerform equipment sanitizations (incubators / hoods / refrigerators)Purchase supplies (GMP)Prepare and send documents to Records Center

INVESTIGATIONS:

Initiate, facilitate, and perform Investigations and NOEs (Notice of Event-NOE) for Environmental samples [NOE for Microbiological Environment Event (MEN)]Inform management of non-conforming events

AUDITS:

Participate in audits (Regulatory, In-house, Corporate)Participate in self-inspections and safety inspectionsRetrieve data when requested by Microbiology management

TRAINING:

Complete assigned training when requiredEnsure training is complete prior to performing tasks

The role requires working more than 40 hours per week (an average of 16 hours per month).  This requirement is factored into the compensation.

This role may be subject to government and/or customer requirements regarding vaccination against COVID-19 that are more stringent than Parexel policy. Accordingly, successful applicants may need to be either vaccinated against COVID-19 or have an approved religious or medical exemption. Employment is contingent on disclosure of your COVID-19 vaccination status and, if relevant, proof of vaccination.

About Parexel

Parexel FSP includes the CMC Operations group.  We provide pharmaceutical and biopharmaceutical companies with qualified and talented technical professionals to support the development and delivery of new therapies.

For results-driven and caring individuals who want to make a meaningful difference in the world, Parexel is trusted by life sciences companies to meet their long-term staffing needs for scientists and engineers and related professionals in discovery and development of novel therapies, keeping patients at the center of everything we do, and where an inclusive community helps you be your best, transforming any career into a life-changing achievement.

Come join us

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